Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000215224
Ethics application status
Approved
Date submitted
4/12/2008
Date registered
28/04/2009
Date last updated
4/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dose response study of folic acid supplementation in New Zealand women.
Scientific title
Effect of mandatory folic acid fortification policy on folate status of New Zealand women of childbearing age.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To calculate a precise estimate of the blood response to folic acid supplementation in New Zealand women at the level proposed by the upcoming fortification program. 4057 0
Improving the folate status of women of childbearing age 4410 0
Condition category
Condition code
Diet and Nutrition 4670 4670 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomized to receive a daily, oral supplement containing either 140mcg or 400mcg of folic acid for 10 months.
Intervention code [1] 3781 0
Other interventions
Comparator / control treatment
A daily, oral, placebo treatment (microcrystalline cellulose), for 10 months.
Control group
Placebo

Outcomes
Primary outcome [1] 5152 0
To evaluate the blood folate status of participants following a daily folic acid supplement of 140mcg or 400mcg for 10 months, to produce a dose-response model. Blood and plasma folate will be measured at weeks 0, 4, 26 and 43.
Timepoint [1] 5152 0
Blood samples will be collected at the start of treatment and then subsequently at weeks 4, 26 and 43.
Secondary outcome [1] 9320 0
Changes in the forms of folate (including unmetabolized folate) found in whole blood and plasma will be compared between the supplement groups from baseline (at the start of treatment) and at week 43.
Timepoint [1] 9320 0
Blood samples will be collected at the start of treatment and week 43

Eligibility
Key inclusion criteria
Healthy New Zealand women of childbearing age.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who were pregnant in the previous year, or who are currently pregnant or planning a pregnancy, taking medications that may affect folate metabolism, or chronic disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Supplements were assigned the letters X, Y and Z. The allocation was handled off-site, and the treatment assignment is held by the principal investigator in a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization sequences were generated by computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 1425 0
New Zealand
State/province [1] 1425 0
Dunedin

Funding & Sponsors
Funding source category [1] 4240 0
University
Name [1] 4240 0
University of Otago Research Grant
Country [1] 4240 0
New Zealand
Primary sponsor type
University
Name
Department of Human Nutrition
Address
University of Otago
PO Box 56
Dunedin 9023
Country
New Zealand
Secondary sponsor category [1] 3813 0
None
Name [1] 3813 0
Address [1] 3813 0
Country [1] 3813 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6292 0
University of Otago Human Ethics Committee
Ethics committee address [1] 6292 0
Ethics committee country [1] 6292 0
New Zealand
Date submitted for ethics approval [1] 6292 0
Approval date [1] 6292 0
Ethics approval number [1] 6292 0
08/063

Summary
Brief summary
This project is being undertaken to determine the effect of folic acid bread fortification on blood folate concentrations in New Zealand women of childbearing age. We will be measuring the response of blood folate to a daily folate vitamin supplement of either 140mcg, 400mcg, and comparing these results to a placebo group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29191 0
Address 29191 0
Country 29191 0
Phone 29191 0
Fax 29191 0
Email 29191 0
Contact person for public queries
Name 12348 0
Dr Lisa Houghton
Address 12348 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
Country 12348 0
New Zealand
Phone 12348 0
+64 3 4797294
Fax 12348 0
Email 12348 0
[email protected]
Contact person for scientific queries
Name 3276 0
Dr Lisa Houghton
Address 3276 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
Country 3276 0
New Zealand
Phone 3276 0
+64 3 4797294
Fax 3276 0
Email 3276 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.